Lurasidone

Important warning for older adults with dementia:

Older adults with dementia (loss of memory and brain function) have an increased chance of death if treated with lurasidone. Older adults with dementia may also have a greater chance of having a stroke or ministroke during treatment with antipsychotics.

Lurasidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking lurasidone.

Important warning for people who have depression:

Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses have a greater chance of becoming suicidal.

This is especially of concern at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

The doctor or pharmacist will give you the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm

Talk to your doctor about the risks of taking lurasidone.

Lurasidone is used to treat the symptoms of schizophrenia (a mental illness that affects how a person thinks, feels and behaves) and bipolar disorder (manic depressive disorder; a disease that causes depression, mania, and other abnormal moods). Lurasidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Lurasidone comes as a tablet to take by mouth. Take with a meal (at least 350 calories) once a day. Take lurasidone at around the same time every day.

Take lurasidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Lurasidone controls your condition but it does not cure it. It may take several weeks or longer before you feel the full benefit of lurasidone. Continue to take lurasidone even if you feel well. Do not stop taking lurasidone without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking lurasidone,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with lurasidone. Other medications may cause dosing changes or extra monitoring when taken with lurasidone. Make sure you have discussed any medications you are currently taking or plan to take before starting lurasidone with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking lurasidone, please get the advice of your doctor or pharmacist.
• the following herbal product may interact with lurasidone: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking lurasidone. Do not start this medication while taking lurasidone without discussing with your healthcare provider.
• tell your doctor if you use or have ever used street drugs or have overused prescription medications and if you have or have ever had a stroke; a ministroke (TIA); chest pain, heart disease, or a heart attack; an irregular heartbeat; heart failure; Parkinson's disease (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); Alzheimer's disease (a brain disease that slowly destroys the memory and ability to think, learn, communicate and handle daily activities); seizures; dementia; breast cancer; trouble keeping your balance; any condition that makes it difficult for you to swallow; high or low blood pressure; high prolactin levels; a high level of fats (cholesterol and triglycerides) in your blood; a low number of white blood cells; kidney disease; liver disease; high blood sugar; or if you or anyone in your family has or has ever had diabetes. Tell your doctor if you have severe vomiting or diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.
• tell your doctor if you are pregnant if you plan to become pregnant, or are breastfeeding. If you become pregnant while taking lurasidone, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking lurasidone.
• you should know that lurasidone may make you drowsy. Do not drive a car or operate hazardous machinery until you know how this medication affects you.
• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. Tell your doctor immediately if you have any of the following symptoms while you are taking lurasidone: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
• you should know that lurasidone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking lurasidone. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that lurasidone may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to exercise or be exposed to extreme heat.
• you should know that lurasidone may cause an increase in weight. It is important to have your weight checked periodically while you are taking this medication.

Do not eat large amounts of grapefruit or drink grapefruit juice while taking this medication.

Take the missed dose with food (at least 350 calories) as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Lurasidone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness, feeling unsteady, or having trouble keeping your balance
• anxiety, restlessness
• weakness
• tiredness
• slow movements or shuffling walk
• nausea, vomiting,
• breast enlargement or discharge
• late or missed menstrual period
• decreased sexual ability

Some side effects can be serious. If you experience any of these symptoms, or those listed in the IMPORTANT WARNINGS and SPECIAL PRECAUTIONS sections, call your doctor immediately:

• seizures
• difficulty swallowing or breathing; hoarseness; difficulty swallowing or breathing; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• shortness of breath
• sore throat, fever, cough, chills, and other signs of infection
• fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
• unusual movements of your face or body that you cannot control
• falling down

Lurasidone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to lurasidone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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